Why can’t I find desiccated thyroid at any pharmacy? Are there really shortages of natural desiccated thyroid? Is natural desiccated thyroid being banned? What happened to Armour by Forest Labs?
Below is a history of the use and production of desiccated thyroid that may help answer your questions.
Natural desiccated thyroid is a treatment that had its first medically documented use in 1891, and successfully. The details of this first and subsequent uses start of page 39 of the Stop the Thyroid Madness book. It rose in popularity and was determined quickly to be a great treatment for hypothyroidism. “Armour” was one of several brands.
In 1906 came the beginning of the FDA’s current regulations with the passage of the Pure Food and Drugs Act. This act was created to prevent the commerce of “adulterated and misbranded food and drugs”.
In 1938 came the Food, Drug and Cosmetic Act which gave the FDA authority to oversee the safety of all three of the latter. Many medications already in use, like Armour and RLC’s Naturethroid, were “grandfathered in”.
In the early 1960’s came the Drug Efficacy Study Implementation (DESI) by the FDA which was meant to classify drugs introduced between 1938 and 1962 as either effective, ineffective, or needing further study. That study was completed in 1969.
Then came 2006 and a new Compliance Policy Guide (CPG, updated June 20th of 2006) which targets the remaining unapproved drugs like natural desiccated thyroid and which ultimately requires the pharmaceuticals which make these drugs to “prove” their effectiveness and safety (i.e. 110 years of millions of safe and effective use of desiccated thyroid by patients is not enough for the FDA, it appears). The proof comes in an NDA (New Drug Application) and rigorous clinical trials, which are quite expensive.
An important sentence in the CPG is found in Section II A: We want to achieve these goals without adversely affecting public health, imposing undue burdens on consumers, or unnecessarily disrupting the market. In other words, all thyroid patients who know the superiority of desiccated thyroid will be keeping the FDA to task for this.
All the above led to April 2009, where patients saw the FDA act upon the compliance by informing two generic makers to cease production, since they started long after. Time Caps Labs was warned in April (scroll down about 3/4th to the heading Unapproved New Prescription Drugs). There is no FDA-listed warning for Major Pharmaceuticals, the other generic maker, but they ceased as well.
In early 2009, Forest Labs reformulated the long popular and effective Armour desiccated thyroid. Patients reported a return of hypothyroid symptoms and new strange ones. So most made a sad exodus from the use of Armour to other brands.
And in this remarkably sad year for desiccated thyroid, 2009, a shortage of US-made desiccated powder occurred, first coming from the only North American manufacturer of the powder: American Labs. The stated cause was demand being greater than supply–an actual possibility since websites like STTM and patients groups were espousing how well it works, so many patients were switching.
By Fall of 2009, The FDA approved US prescriptions to be used at Canadian Pharmacies for Erfa’s “Thyroid”. Compounding desiccated thyroid also found more business in the US.
January 2010 saw RLC Labs, the makers of Naturethroid, beginning to send out supplies of their brand.
Read the Options for Thyroid Treatment to see all your possibilities.
